Outcome parameters for trials in atrial fibrillation: executive summary

Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF- related morbidity and mortality is desirable for any clinical trial in AF.

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kardiologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Cardiac and Cardiovascular Systems hsv//eng
atrial brillation
outcome parameter
randomized trial
therapy
treatment
end-point
quality of life
stroke death
left ventricular function
catheter ablation
antiarrhythmic drugs
cardioversion
rate control
rhythm control
anticoagulation
controlled trial

Auricchio, Angelo (author)
Bax, Jeroen (author)
Crijns, Harry (author)
Camm, John (author)
Diener, Hans-Christoph (author)
Goette, Andreas (author)
Hindricks, Gerd (author)
Hohnloser, Stefan (author)
Kappenberger, Lukas (author)
Kuck, Karl-Heinz (author)
Lip, Gregory Y. H. (author)
Olsson, BertilLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)kard-bol (author)
Meinertz, Thomas (author)
Priori, Silvia (author)
Ravens, Ursula (author)
Steinbeck, Gerhard (author)
Svernhage, Elisabeth (author)
Tijssen, Jan (author)
Vincent, Alphons (author)
Breithardt, Guenter (author)
KardiologiSektion II (creator_code:org_t)

In:European Heart Journal: Oxford University Press (OUP)28:22, s. 2803-28171522-96450195-668X

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